1. Field of the Invention
This invention relates generally to bowel management systems including rectal catheters, and, more particularly, to system wherein the rectal catheter has sensors embedded therein for physiologic monitoring/detection, screening of body state conditions such as temperature, oxygen saturation, infection, diseases, or other abnormalities, via interface with intestinal and intestinal contents whether solid, liquid or gas for example.
2. Related Art
Rectal thermometry and stool sampling are well known in the art of bowel management. However, current rectal thermometers require either repeated placement of a thermometer into the rectal vault for a short duration in order to get a temperature reading. Similarly, stool sampling techniques known in the art generally involve a messy process of either sampling stool that has been deposited by the patient in a receptacle such as a bed and bed pan or collection reservoir, or in some situations by physically removing stool from a patient. Both methods are unclean, messy, inexact, and unnecessarily expose the caregiver to the stool, which could contain hazardous infectious organisms and contaminated blood, and may also be extremely uncomfortable or hazardous for the patient.
There are many known catheter systems with physiologic sensing capability embedded in them for measuring pressure in the body and there are known rectal temperature probes. However, there are no known combination bowel management systems with both indwelling catheter portions and physiologic sensing capabilities.
The current devices to measure rectal temperature are inconsistent (due to uncontrolled placement of the temperature probe during each reading) and do not always gather an accurate measurement. None of these known rectally inserted probes can accurately interface with the anal canal. Other physiologic measurements such as oxygen saturation are usually done elsewhere on the body and while accurate, the methods include the caregiver managing additional equipment and may subject the patient to multiple tests. No known oxygen saturation monitors can simultaneously give measurements from the portal or mesenteric and the systemic circulations. Also, no known probes are for recording oxygen saturation from the portal or mesenteric circulation. Known stool sampling devices and methods are inconsistent, messy and subject the caregiver to unnecessary biological hazards.
The Bowel Management System (BMS) catheter which is used in patients to manage the output of stool resides atraumatically in the anorectum of the human and makes contact with the surrounding mucosa of the rectum and/or anal canal. This system is ideally of the basic type described in U.S. Ser. No. 10/225,820, pending, published Feb. 26, 2004, as Pub. No. US 2004/0039348A1, and owned by the assignee of the present invention, and the entire disclosure of which is incorporated herein by reference. Alternatively, the system of the present invention can include a rectal catheter (but without the cuff-shaped balloon-like bolster of FIG. 1), for example as of the type shown in FIG. 2, although not limited thereto. These locations of contact have proven to be preferred locations for sensing physiologic conditions such as temperature and oxygen saturation levels (experimentally). Dual sensors that measure portal or mesenteric (rectal) and systemic (anal canal) indices would have potential comparative values. Also due to the controlled passage of stool through the BMS, the BMS presents a more controlled way to sample the content of the stool when the stool is first exiting the anorectum for infections and blood content. Because the BMS resides in a patient's anal canal for up to about 29 days and has a portion that exits the anal canal within easy view of the caregiver, the BMS allows for placement of one or more physiologic sensors, in keeping with the present invention, in or attached to the indwelling portion of the catheter with corresponding readout device of the sensors outside the body of the patient by the caregiver.
Previously known devices to measure rectal temperature are inconsistent in performance (due to uncontrolled placement of the temperature probe during each reading) and do not always gather an accurate measurement. None of these known rectally inserted probes can accurately interface the anal canal. Other physiologic measurements such as oxygen saturation are usually done elsewhere on the body and while accurate, the methods include the caregiver managing additional equipment and possibly subjecting the patient to multiple tests. No known oxygen saturation monitors can simultaneously give measurements from the portal or mesenteric and the systemic circulations. Also, there are no known probes for recording oxygen saturation from the portal or mesenteric circulation. Known stool sampling devices and methods are messy and subject the caregiver to unnecessary hazards.